A placebo-controlled, double-blind Phase 3 study to assess Rocatinlimab in Prurigo nodularis
Descrizione riassuntiva dello studio
This is a Phase III study, the early development phase of drugs for humans. The researchers will examine and provide information on how well Rocatinlimab works and how well it is tolerated compared to placebo in a person for the treatment of PN, and whether it causes side effects. The study may last up to 68 weeks for each participant and includes a pre-screening period of up to 4 weeks, a 52-week treatment period, and a safety follow-up appointment 16 weeks after the last dose of Rocatinlimab. The study will include men and/or women who are at least 18 years old and have PN that has been diagnosed by a doctor at least 3 months prior to signing the informed consent. Participants must have used topical corticosteroids for the daily treatment of PN for at least 14 days (or for the recommended duration of drug use) without a reduction or disappearance of PN symptoms before signing the informed consent. A sufficient period must have elapsed between the previous PN treatment and the study treatment. Participants with other serious illnesses (e.g., cancer, severe depression, certain heart diseases) that are prone to severe allergic reactions or infections, or who have taken or are taking other medications not allowed in the study, are not permitted to participate in the study. Pregnant or breastfeeding participants are not allowed to participate in the study.
(BASEC)
Intervento studiato
Participants will receive either Rocatinlimab (2 different doses) or a placebo as an injection directly under the skin.
Rocatinlimab is a protein-based medication. It has been specifically designed to bind to the OX40 protein on cells involved in inflammatory processes and to interfere with its function.
(BASEC)
Malattie studiate
Prurigo nodularis – in adult participants whose disease cannot be adequately controlled with topical therapies or who are not suitable for topical therapies.
(BASEC)
- Clinical diagnosis of PN (defined by core symptoms according to the US expert panel consensus [Elmariah et al, 2021]), present for at least 3 months prior to signing the informed consent. - At least ≥ 20 PN nodules at initial screening and on Day 1 prior to randomization with bilateral distribution on both legs and/or both arms and/or the trunk. (BASEC)
Criteri di esclusione
- Skin or systemic diseases, excluding prurigo nodularis, that have been active or require treatment within the last 3 months and that may affect the evaluation of study outcomes. - Secondary prurigo nodularis due to medications. - Secondary prurigo nodularis due to neurological or psychiatric conditions (e.g., notalgia paresthetica, brachioradial pruritus, neurotic excoriations, obsessive-compulsive disorder, delusional parasitosis). - History of severe immunological reactions (e.g., serum sickness, anaphylaxis, or anaphylactic reaction) to another biologic or an excipient of Rocatinlimab. (BASEC)
Luogo dello studio
Basilea, Berna, Zurigo
(BASEC)
Sponsor
AMGEN
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof Dagmar Simon
+41 31 632 22 18
dagmar.simon@clutterinsel.chInselspital Bern Universitaetsklinik fuer Dermatologie
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
03.10.2024
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
20230053 - A Phase 3, 52-Week, Multicenter, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy, Safety, and Tolerability of Rocatinlimab in Adult Subjects With Prurigo Nodularis Who are Inadequately Controlled on Topical Therapies (BASEC)
Titolo accademico
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Ulteriori informazioni sullo studio
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Risultati dello studio
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